Systems and methods for treating cancer using brachytherapy

ABSTRACT

Systems and methods are provided for treating cervical and/or uterine cancers in brachytherapy with an intracavitary brachytherapy applicator. The system comprises a tandem adapted for insertion into a cervix of a patient. An ovoid assembly comprises first and second inflatable ovoids and an ovoid support mechanism. The first and second inflatable ovoids are adapted for insertion within fornices of a patient. First and second retractors are adapted to be coupled to the ovoid assembly. The first retractor is adapted to be positioned to retract the bladder of a patient during treatment. The second retractor is adapted to be positioned to retract the rectum of a patient during treatment. The tandem and the first and second inflatable ovoids are adapted to be coupled to a radioactive source to deliver an implant radiation dose suitable for cancer treatment at a cancerous cervical treatment site in a patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/081,147, filed Mar. 25, 2016, which is a continuation of U.S. patentapplication Ser. No. 13/719,968, filed Dec. 19, 2012, now U.S. Pat. No.9,295,856, which is a continuation-in-part of U.S. patent applicationSer. No. 13/386,644, filed Jan. 23, 2012, now U.S. Pat. No. 9,295,491,which is a national phase application of PCT/US2010/043121, filed Jul.23, 2010, which claims the priority benefit of U.S. ProvisionalApplication Ser. No. 61/271,774, filed on Jul. 24, 2009, the entirety ofeach of which is hereby incorporated by reference herein.

BACKGROUND Field of the Invention

The present application relates to devices and methods for treatingcancer using brachytherapy. In particular, the present applicationrelates to devices and methods for treating cervical and/or uterinecancers in brachytherapy with an intracavitary brachytherapy applicator.

Description of the Related Art

“Brachy” is derived from the Greek word “brachio” meaning short range,and in reference to brachytherapy is defined as “Short Range Treatmentwith a Radioisotope.” Five years after ²²⁶Ra was discovered by Marie andPierre Curie in Paris, Alexander Graham Bell suggested the implantationof radioactive sources directly into the tumors. That same year in 1903,two cases of facial basal cell carcinoma were treated, using ²²⁶Rasurface molds in St. Petersburg.

Brachytherapy typically offers low morbidity by delivering a high doseof ionizing radiation to the target volume, sparing surrounding healthytissue with rapid dose fall off outside the implanted volume. Selectiveplacement of the radioactive sources allow the dose distribution to bemanipulated to match the target shape. Brachytherapy can be used intreating most areas of the body and can be used alone or in conjunctionwith External Beam Radiotherapy, Chemotherapy, and Surgery formanagement of cancer. HDR and LDR brachytherapy are well-establishedtechniques with a long history of use in treatment of cervical anduterine cancers. The scientific principle behind this technology is thata highly radioactive source inside an afterloader passes through atransfer guide tube into an applicator implanted in the patient. Theradioactive source is programmed to remain in its precise location for agiven period to deliver radiation dose according to the prescription.This can be effective in treating cancers of the cervix and uterus.

One known applicator for use in brachytherapy is theFletcher-Suit-Delclos (FSD) afterloading intracavitary brachytherapyapplicator for treatment of cervical and uterine cancers. Intracavitarybrachytherapy procedure using FSD applicator for treatment of cervicaland uterine cancers is tedious and time consuming. The procedurerequires the patient to be consciously sedated or anesthetized as theprocedure can be painful and lengthy with the complex design of thecurrent available applicators requiring one to two nurses in assistingthe radiation oncologist in implanting the applicator. The non-idealgeometry of the applicator placement, and the inadequate andoccasionally painful placement of the vaginal packing retractor used toretract the bladder and the rectum from the plane of the implant, makethe radiation dosimetry non-ideal, with high doses reaching the bladderor the rectum causing unwanted morbidities in some cases. Accordingly,in order to keep the radiation dose within the respective tolerancedoses of the organs at risk, in some cases a user lowers the dose to thetumor; thus potentially causing the cancer to reoccur. Some optimizationalgorithms are currently used in the HDR treatment planning systems,however these cannot and do not adequately substitute or replace ageometrically optimum implant.

In recent years many intracavitary applicators based on the FSDapplicator concept have been designed, and used in the clinic, e.g., theWeek, Williamson, Henschke and Mick applicators. The typicalprescription requires 3 or 4 implants, one week apart, on the samepatient. The traditional FSD applicator normally consists of 8-piecesassembled as the patient rests supine in the stirrup position. Thecurrent clinical procedure using FSD applicator is typically lengthy,painful, and often requires anesthetics, or conscious sedation. Theproblems outlined herein have made patients request alternativetreatments such as surgery or use of Intensity Modulated Radiotherapy(IMRT). However, the intracavitary brachytherapy for treating cervicaland uterine cancers should not be replaced with IMRT since intracavitarybrachytherapy provides more conformal therapy, less integral dose, andsuperior sparing of the organs at risk.

SUMMARY OF SOME EMBODIMENTS

The present application relates to devices and methods for treatingcervical and/or uterine cancers in brachytherapy with an intracavitarybrachytherapy applicator to harness the benefits of brachytherapy inaddition to easing and improving the implant procedure. Some embodimentscomprise an advanced applicator system built for high and/or low doserate (HDR and LDR) brachytherapy using a novel and innovative designwith the aim of easier implantation of the applicator.

According to some embodiments, an intracavitary brachytherapy applicatorhas a tandem and first and second inflatable ovoids. The tandem andovoids are adapted to deliver an implant radiation dose for treatment ofa patient. In some embodiments the applicator comprises one or moreretractors. The ovoids are preferably coupled to an ovoid assembly tosupport the ovoids and to control the relative position of the ovoids.The tandem is preferably releasably coupled to the ovoid assembly and isadjustable relative to the ovoid assembly. The tandem preferably pivotsand translates relative to the ovoid assembly. The tandem is preferablycoupled to the ovoid assembly in a manner that limits or restrictsrotation of the tandem about a longitudinal axis of the tandem. In someembodiments retractors are releasably coupled with the ovoid assembly. Afirst retractor can be positioned to retract the bladder of a patientduring treatment and a second retractor can be positioned to retract therectum of a patient during treatment. The retractors are preferablyinflatable to at least partially retract the bladder and rectum from atreatment site. In some embodiments the tandem is preferably integratedwith an endoscope to facilitate treatment. Embodiments of the presentapplication provide advantages over the Fletcher-Suit-Delclos (FSD)afterloading intracavitary brachytherapy applicators.

According to one embodiment, an applicator comprises a tandem catheterand comprises two colpostats arranged for introduction of radioactivesources for intracavitary brachytherapy. The tandem can be integratedwith an endoscope in some embodiments that gives the capability oflocating the cervical os and guiding the tandem into the uterine canal.The conventional FSD applicator colpostats are made of variously sizedrigid caps. According to one embodiment, the applicator comprises twoinflatable ovoid balloons with the capability of expansion to multiplesizes through iodinated saline. To replace inadequate retraction offeredby currently used vaginal packing, two additional semi-cylindricalballoons are preferably attached to the ovoid assembly for retractingthe bladder and rectum to lower the radiation dose received by theseorgans. The applicator preferably provides a geometrically optimumimplant where the tandem is positioned to bisect the ovoids, the ovoidsare inflated and positioned to the largest size appropriate to fit theanatomy of the patient, and the bladder and the rectum are pushed awayfrom a plane of the implant by one or more retractors. In someembodiments the retractors push the bladder and rectum away from a planeof the implant by at least two centimeters. The applicator implementsinflatable retractors for isolating the patient's bladder and the rectumfrom radioactive sources, lowering the radiation dosage absorbed bythese critical structures. An endoscope integrated with the tandem, insome embodiments, can provide advantages such as, for example, locatingthe cervical os more easily, limiting uterine perforations, sounding theuterus, and guiding the tandem through the uterine canal.

According to one method, an embodiment of the applicator is providedhaving a tandem and a dual ovoid assembly. The tandem may have afiberoptic endoscope integrated with it, so the cervical os can easilybe found instead of the patient being blindly poked with a speculumplaced in the vaginal canal. The tandem and the collapsed balloon dualovoid assembly can easily be inserted as a single unit into the vaginalcanal. The tandem may be guided by endoscope into the cervical os anduterine canal, where the ovoids may be placed in the cervical fornices.The ovoids can comprise two balloons that are inflated with desiredvolumes of iodinated saline. The ovoids can conform to the cervicaltumor and can provide adaptive brachytherapy. The applicator can allowfor the tandem and ovoids to be assembled and/or configured rapidly.Adjustments to the system can be completed outside of the patient,similar to a laproscopy procedure. Advantages of the applicator systemsand methods of use include simplification of the use of the implant,utilizing fewer parts, adjustable ovoids fitting the patient forniceswith comfort, and the inflatable retraction mechanism to separate andgive adequate distance to the bladder and rectum. This will optimize thedose to the cervix and uterus, minimizing the dose to these criticalstructures.

In some embodiments, advantages of applicator systems and methods mayinclude easier and faster implantation. The applicator can cause less orno pain to the patient. The applicator can reduce complications to thepatient. The applicator can have simple and integrated applicator parts.Methods of using the applicator and performing treatments can bereproducible. The applicator can provide improved implant geometry. Theapplicator can be configured to provide for manipulations to be doneoutside the vaginal and uterine canals, thus making the implant lessinvasive and geometrically advantageous. The applicator can provideimproved radiation dosimetry and lower dose to bladder and rectum.

According to one embodiment, a system for treating cervical and/oruterine cancers in brachytherapy with an intracavitary brachytherapyapplicator comprises a tandem adapted for insertion into a cervix of apatient. The tandem comprises an endoscopic viewing element tofacilitate treatment and one or more radiographic markers. An ovoidassembly comprises first and second adjustably inflatable ovoids and anovoid support mechanism. The ovoid support mechanism is adapted tosupport the ovoids and to allow for user manipulation to control therelative position of the ovoids for insertion of the ovoids within thefornices of a patient. The first and second adjustably inflatable ovoidshave a deflated configuration for insertion into a patient and one ormore adjustably inflated configurations for positioning the ovoidassembly during treatment. The first and second ovoids each have one ormore radiographic markers. The ovoid assembly comprises a tandemconnector adapted to releasably and adjustably couple the tandem to theovoid assembly to allow for pivotal and translational motion of thetandem relative to the ovoid assembly and to limit rotational movementof the tandem about a longitudinal axis of the tandem. First and secondadjustably inflatable retractors are adapted to be releasably coupled tothe ovoid assembly at first and second retractor connector portions. Thefirst and second inflatable retractors have a deflated configuration forinsertion into a patient and an adjustably inflated configuration forretraction of tissue during treatment. The first retractor is adapted tobe positioned to retract the bladder of a patient during treatment andthe second retractor is adapted to be positioned to retract the rectumof a patient during treatment. The tandem and the first and secondinflatable ovoids are adapted to be coupled to a radioactive source todeliver an implant radiation dose suitable for cancer treatment at acancerous cervical treatment site in a patient.

According to another embodiment, a system for treating cervical and/oruterine cancers in brachytherapy with an intracavitary brachytherapyapplicator comprises a tandem adapted for insertion into a cervix of apatient. An ovoid assembly comprises first and second inflatable ovoidsand an ovoid support mechanism. The first and second inflatable ovoidsare adapted for insertion within fornices of a patient. First and secondretractors are adapted to be coupled to the ovoid assembly. The firstretractor is adapted to be positioned to retract the bladder of apatient during treatment and the second retractor is adapted to bepositioned to retract the rectum of a patient during treatment. Thetandem and the first and second inflatable ovoids are adapted to becoupled to a radioactive source to deliver an implant radiation dosesuitable for cancer treatment at a cancerous cervical treatment site ina patient.

According to another aspect, a method of treating cervical and/oruterine cancers in brachytherapy with an intracavitary brachytherapyapplicator comprises providing an intracavitary brachytherapy applicatorhaving a tandem, an ovoid assembly comprising first and secondinflatable ovoids and an ovoid support mechanism, and first and secondretractors adapted to be coupled to the ovoid assembly. The tandem isinserted into a cervix of a patient. The first and second inflatableovoids are inserted within fornices of a patient. The first and secondretractors are inserted within a patient. The first and secondinflatable ovoids are inflated within a patient. The bladder of apatient is retracted from a treatment site. The rectum of a patient isretracted from a treatment site. An implant radiation dose suitable fortreatment is delivered at a treatment site.

According to another aspect, a method of treating cervical and/oruterine cancers in brachytherapy with an intracavitary brachytherapyapplicator can comprise one or more of the following steps. First andsecond retractors can be coupled to the ovoid assembly prior toinsertion within a patient. The tandem and the first and secondinflatable ovoids can be coupled to a radioactive source. Retracting thebladder can comprise inflating the first retractor. Retracting therectum can comprise inflating the second retractor. The tandem can becoupled to the ovoid assembly. The tandem can be translated relative tothe ovoid assembly. The tandem can be pivoted relative to the ovoidassembly. The tandem can comprise an endoscopic viewing element. Aportion of the anatomy of the patient can be viewed with the viewingelement upon insertion of the tandem within the patient. Rotationalmovement of the tandem about a longitudinal axis of the tandem can belimited by a connection between the tandem and ovoid assembly.

According to some embodiments, a system for treating cervical and/oruterine cancers in brachytherapy with an intracavitary brachytherapyapplicator comprises a tandem adapted for insertion into a cervix of apatient. An ovoid assembly comprises first and second inflatable ovoidsand an ovoid support mechanism. The first and second inflatable ovoidsare adapted for insertion within fornices of a patient. The ovoidsupport mechanism is adapted to support the ovoids and to allow for usermanipulation to control the relative position of the ovoids forinsertion of the ovoids within the fornices of a patient. The ovoidsupport mechanism comprises first and second handles wherein the handlesare configured to allow for user manipulation to control the relativeposition of the ovoids using a coarse adjustment mechanism in a firstconfiguration and using a fine adjustment mechanism in a secondconfiguration. First and second retractors are adapted to be coupled tothe ovoid assembly. The first retractor is adapted to be positioned toretract the bladder of a patient during treatment and the secondretractor is adapted to be positioned to retract the rectum of a patientduring treatment. The tandem and the first and second inflatable ovoidsare adapted to be coupled to a radioactive source to deliver an implantradiation dose suitable for cancer treatment at a cancerous cervicaltreatment site in a patient.

According to some embodiments, a system for treating cervical and/oruterine cancers in brachytherapy with an intracavitary brachytherapyapplicator comprises a tandem adapted for insertion into a cervix of apatient. An ovoid assembly comprises first and second inflatable ovoidsand an ovoid support mechanism. The first and second inflatable ovoidsare adapted for insertion within fornices of a patient. The ovoidassembly comprises a tandem connector adapted to releasably andadjustably couple the tandem to the ovoid assembly. The ovoid assemblycomprises a first configuration wherein one or more handles coupled tothe tandem connector are in an open position and adapted for pivotal andtranslational movement of the tandem, and a second configuration whereinthe one or more handles coupled to the tandem connector are in a closedposition and adapted to clamp the tandem connector to limit movement ofthe tandem. First and second retractors are adapted to be coupled to theovoid assembly. The first retractor is adapted to be positioned toretract the bladder of a patient during treatment and the secondretractor is adapted to be positioned to retract the rectum of a patientduring treatment. The tandem and the first and second inflatable ovoidsare adapted to be coupled to a radioactive source to deliver an implantradiation dose suitable for cancer treatment at a cancerous cervicaltreatment site in a patient.

According to some embodiments, a system for treating cervical and/oruterine cancers in brachytherapy with an intracavitary brachytherapyapplicator, comprises a tandem adapted for insertion into a cervix of apatient. An ovoid assembly comprises first and second inflatable ovoidsand an ovoid support mechanism. The first and second inflatable ovoidsare adapted for insertion within fornices of a patient. First and secondretractors are adapted to be coupled to the ovoid assembly. The firstretractor is adapted to be positioned to retract the bladder of apatient during treatment and the second retractor is adapted to bepositioned to retract the rectum of a patient during treatment. Thefirst and second retractors are adapted to be releasably coupled to theovoid assembly. The first and second retractors have attachmentmechanisms comprising spring actuated lock mechanisms adapted to providefor adjustment of the position of the retractor and to provide for asnap fit connection with the ovoid assembly. The tandem and the firstand second inflatable ovoids are adapted to be coupled to a radioactivesource to deliver an implant radiation dose suitable for cancertreatment at a cancerous cervical treatment site in a patient.

Still other aspects, features, and attendant advantages of the presentapplication will become apparent to those skilled in the art from areading of the following detailed description of embodiments constructedin accordance therewith, taken in conjunction with the accompanyingdrawings. Aspects, features, and attendant advantages of the presentapplication provide improvements over known devices, systems andmethods. Some devices, systems and methods related to brachytherapy aredescribed in more detail in the following references, each of which ishereby incorporated by reference herein in its entirety. 1. J. Rahimian,Y. Qian, R. Kagan, Effects of Applicator Spatial Placement Variations onCumulative Dose to Point A in the Treatment of Cervical Cancer with 3HDR Intracavitary Brachytherapy Treatments. Medical Physics, Vol. 26,No. 6, p. 1142, 1999 (abstract); 2. Faiz M. Khan The Physics ofRadiation Therapy. Third Edition. Lippincott Williams & WilkinsPublishers, 2003; 3. H. K. Malhotra, J. S. Avadhani, S. F. deBoer, et.al. Duplicating a tandem and ovoids distribution with intensitymodulated radiotherapy: a feasibility study. J. of Appl. Clin. Med.Phys. Vo. 8, No 3 (2007).

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a side view of an assembled minimally invasiveintracavitary brachytherapy applicator system according to embodimentsof the present application.

FIG. 2 illustrates a perspective view of a distal portion of theapplicator system of FIG. 1 according to embodiments of the presentapplication.

FIG. 3 illustrates a perspective view of a proximal portion of theapplicator system of FIG. 1 according to embodiments of the presentapplication.

FIG. 4 illustrates a side perspective view of the applicator system ofFIG. 1 according to embodiments of the present application.

FIG. 5 illustrates a rear perspective view of the proximal portion ofthe applicator system of FIG. 1 according to embodiments of the presentapplication.

FIG. 6 illustrates a front view of the distal portion of the applicatorsystem of FIG. 1 according to embodiments of the present application.

FIG. 7 illustrates a side view of an assembled minimally invasiveintracavitary brachytherapy applicator system similar to the systemshown in FIG. 1 without the retractor assemblies.

FIG. 8 illustrates a front side perspective view of the applicatorsystem of FIG. 7 according to embodiments of the present application.

FIG. 9 illustrates a rear side perspective view of the applicator systemof FIG. 7 according to embodiments of the present application.

FIG. 10 illustrates a top view of the applicator system of FIG. 7according to embodiments of the present application.

FIG. 11 illustrates a top rear view of the applicator system of FIG. 7according to embodiments of the present application.

FIG. 12 illustrates a top front view of the applicator system of FIG. 7according to embodiments of the present application.

FIG. 13 illustrates a tandem portion of an applicator system accordingto embodiments of the present application.

FIG. 14 illustrates an endoscopic tandem portion of an applicator systemaccording to embodiments of the present application.

FIG. 15 illustrates a side perspective view of another assembledminimally invasive intracavitary brachytherapy applicator systemaccording to embodiments of the present application.

FIG. 16 illustrates an exploded view of the applicator system of FIG.15.

FIG. 17 illustrates rear side perspective view of the applicator systemof FIG. 15 according to embodiments of the present application.

FIG. 18 illustrates a front side perspective view of the applicatorsystem of FIG. 15 according to embodiments of the present application.

DETAILED DESCRIPTION OF EMBODIMENTS

The present application relates to devices and methods for treatingcervical and/or uterine cancers in brachytherapy with an intracavitarybrachytherapy applicator. According to some embodiments, anintracavitary brachytherapy applicator has a tandem and first and secondinflatable ovoids. The tandem and ovoids are adapted to deliver animplant radiation dose for treatment of a patient. In some embodimentsthe applicator comprises one or more retractors. The ovoids arepreferably coupled to an ovoid assembly to support the ovoids and tocontrol the relative position of the ovoids. The tandem is preferablyreleasably coupled to the ovoid assembly and is adjustable relative tothe ovoid assembly. The tandem preferably pivots and translates relativeto the ovoid assembly. The tandem is preferably coupled to the ovoidassembly in a manner that limits or restricts rotation of the tandemabout a longitudinal axis of the tandem. In some embodiments retractorsare releasably coupled with the ovoid assembly. In other embodimentsretractors can be fixed or attached to the ovoid assembly. A firstretractor can be positioned to retract the bladder of a patient duringtreatment and a second retractor can be positioned to retract the rectumof a patient during treatment. The retractors are preferably inflatableto at least partially retract the bladder and rectum from a treatmentsite. In some other embodiments the retractors are not inflatable. Insome embodiments the tandem is preferably integrated with an endoscopeto facilitate treatment.

In some embodiments, an advanced and minimally invasive cervical anduterine HDR and/or LDR applicator system comprises a tandem catheteradapted to be placed inside the uterine canal with two inflatablecatheters placed next to the cervical fornices, while using twoinflatable semi-cylindrical balloons to retract the bladder and rectumaway from the radioactive sources. The tandem central catheter caninclude endoscopic fiber optics to transmit images of the cervical os,as well as the uterine canal as it is placed. This can facilitateinsertion, limit multiple pokes of the cervix, may limit injury to thecervix and uterine perforation causing injury and infection to theuterus as well as to the small bowel. In addition, placement of theapplicator is likely to be much faster, preferably on the order ofminutes rather than over an hour. The endoscopic tandem and the dualovoid assembly can be configured as a single piece that advantageouslyenables the radiation oncologist to implant the applicator possiblywithout a speculum, reducing pain, anesthetics, and stress on thenursing personnel and the radiation oncologist.

With reference to FIGS. 1-14, according to some embodiments, systems fortreating cervical and/or uterine cancers in brachytherapy with anintracavitary brachytherapy applicator 100 comprise a tandem 102 adaptedfor insertion into a cervix of a patient. The tandem 102 can comprise anendoscopic viewing element 104 to facilitate treatment and one or moreradiographic markers 106.

An ovoid assembly 110 comprises first and second adjustably inflatableovoids 112, 114 and an ovoid support mechanism 116. The ovoid supportmechanism 116 is adapted to support the ovoids 112, 114 and to allow foruser manipulation to control the relative position of the ovoids forinsertion of the ovoids within the fornices of a patient. The first andsecond adjustably inflatable ovoids 112, 114 have a deflatedconfiguration for insertion into a patient and one or more adjustablyinflated configurations for positioning the ovoid assembly duringtreatment. The first and second ovoids 112, 114 each have one or moreradiographic markers 120, 122. The ovoid assembly 110 comprises a tandemconnector 124 adapted to releasably and adjustably couple the tandem 102to the ovoid assembly 110 to allow for pivotal and translational motionof the tandem 102 relative to the ovoid assembly 110 and to limitrotational movement of the tandem 102 about a longitudinal axis of thetandem.

First and second adjustably inflatable retractors 130, 132 are adaptedto be releasably coupled to the ovoid assembly at first and secondretractor connector portions 134, 136. The first and second inflatableretractors 130, 132 have a deflated configuration for insertion into apatient and an adjustably inflated configuration for retraction oftissue during treatment. The first retractor 130 is adapted to bepositioned to retract the bladder of a patient during treatment and thesecond retractor 132 is adapted to be positioned to retract the rectumof a patient during treatment. The tandem 102 and the first and secondinflatable ovoids 112, 114 are adapted to be coupled to a radioactivesource to deliver an implant radiation dose suitable for cancertreatment at a cancerous cervical treatment site in a patient.

Some embodiments are described in more detail below. The applicatorsystems and methods can have one or more of the following advantageouscharacteristics in some embodiments.

Applicator Assembly

Some embodiments include applicator systems 100 that can bepre-assembled before insertion into the patient such that only a few,and in some cases, preferably one or two adjustable and integratedpieces are inserted into the patient. In contrast, the current FSDapplicators require about 8 pieces to be assembled while inserted withina patient during use. Accordingly, use of embodiments of the presentapplication preferably makes insertion and manipulation of the implantsfaster, more dosimetrically optimal, lessens the need for anesthetics,and reduces pain to the patient.

Ovoid Assembly

As shown in FIGS. 1-12, the applicator system 100 comprises a pair ofovoids 112, 114 in the form of inflatable balloons, each with varyingvolume capacity, rather than solid caps of varying sizes currently usedas colpostats. The inflatable balloon ovoids 112, 114 can advantageouslyand naturally take on the shape of mini, small, medium, and/or largesize ovoids depending on the size of the patient's anatomy. In someembodiments, the ovoids 112, 114 can be independently inflated to 4different sizes of the following approximate dimensions:

SIZE WIDTH LENGTH VOLUME Mini 1.4 cm 3.0  5 cc Small 2.0 cm 3.0 10 ccMedium 2.5 cm 3.0 15 cc Large 3.0 cm 3.0 21 cc

Depending on the patient's anatomy, and the extent, and the size, andthe side of the gross disease, the two ovoids 112, 114 can be inflatedwith different volumes. For example, one ovoid can be inflated as smallsize and the other as medium size ovoid. The left and the right sideovoids are preferably substantially identical in size, even though atthe radiation oncologist's and/or the physicist's discretion, one can beinflated larger than the other depending on the extent of the diseaseand size of the fornices. In some other embodiments the ovoids can havedifferent maximum sizes.

As described above and as shown in FIGS. 1-12, the ovoid supportmechanism 116 is adapted to support the ovoids 112, 114 and to allow foruser manipulation to control the relative position of the ovoids forinsertion of the ovoids within the fornices of a patient. The ovoidsupport mechanism 116 supports first and second catheter shafts 140, 142coupled with the ovoids for delivering radiation to the ovoids. Theovoid support mechanism also comprises first and second handle portions144, 146 coupled for pivotatal movement relative to one another.Movement of the handle portions 144, 146 relative to each other controlsthe distance between the first and second ovoids 112, 114. The relativeposition of the handle portions 144, 146 can be fixed by tightening aknob 150 at an upper portion of the ovoid support mechanism 116. A lowerportion of the ovoid support mechanism 116 comprises the tandemconnector 124. The tandem connector 124 comprises a slot 152 forreceiving the tandem 102, a spring loaded ball or pin 154 on a firstside of the slot 152 and a flat surface 156 on a second side of the slot152. The tandem 102 comprises a groove 160 for translationally andpivotally coupling to the spring loaded ball or pin 154 when the tandemis positioned in the slot 152. A flat surface 162 of the tandem ispositioned opposite the groove 160 and interfaces with the flat surface156 of the tandem connector 124 when the tandem is positioned in theslot 152 to limit rotational movement of the tandem 102 about alongitudinal axis.

Tandem

Tandems 102 can have different shapes and configurations. For example,some embodiments include tandems having a curved portion 164 of 0, 15,30, 45, and 60 degrees. The tandem 102 can be provided with or withoutendoscopic capabilities. Additionally, a tandem 102 can includeradiographic markings, for example, one-cm markings, on it formeasurement and/or viewing. The markers 106 can be positioned near thetandem tip 166 and/or near the tandem connector portion 124. The tandem102 and the ovoids 112, 114 are coupled to catheter shafts 138, 140, and142, respectively. The total internal length of the catheters 138, 140,and 142 are preferably substantially identical for both the tandem 102and the ovoids 112, 114. In some other embodiments, the total lengthscan vary. The internal length of the catheter shafts 138, 140, 142 ofthe tandem 102 and the two ovoids 112, 114 is preferably about 35 cm.Longer or shorter catheter lengths are also contemplated.

Tandem Coupling

As mentioned above, a tandem connector 124 mechanism is provided forcoupling the tandem 102 with the ovoid assembly 110. The mechanismpreferably enables the tandem 102 to pivot in the anterior/posteriordirection about a point in reference to the ovoids 112, 114 using aspring-loaded ball bearing 154 within the ovoid assembly 110 tointerface with a groove 160 on a side of the tandem as best seen in FIG.13. The mechanism also preferably allows the user to translate and/orpivot the tandem to keep it at the mid-plane of the ovoids 112, 114during treatment. Enabling the user to position the tandem 102 to bisectthe ovoids 112, 114 helps to improve implant geometry and dosedistribution. In some embodiments, a side of the tandem opposite thegrooved side preferably has a flattened surface 162 that contacts aflattened surface 152 of the ovoid assembly 110 to limit inadvertentrotation of the tandem 102 during manipulation and treatment.Accordingly, the mechanism preferably limits the tandem from rotationaround a longitudinal axis of the tandem and permits translational andpivotal motion to achieve an advantageous mid-plane position relative tothe ovoids 112, 114.

Retractors

Retractor balloons 130, 132 are preferably added to the intracavitarybrachytherapy applicator to retract the bladder and the rectum from theradiation sources, thus lowering the dose to these critical structures.This can reduce, and in some cases eliminate, the need to use of vaginalpacking after the applicator is in place. The retractor balloons 130,132 are coupled to catheters 184, 186 that are preferably anchored onthe ovoid assembly 110. The retractor balloons 130, 132 are preferablyinflated with saline. Other suitable inflation mediums can also be used.The balloons can be semi-cylindrical or semi-ellipsoide when inflated topush the vaginal mucosa, bladder, and rectum away from the radiationsite. Balloons having other suitable shapes and sizes for providingretraction can also be used. The retraction mechanism is preferablyinflatable to retract the bladder and the rectum by at least about 2 cmaway from a plane of the implant defined at the plane of the tandembisecting the ovoids. The retraction mechanism preferably retractsequidistance from the plane of the implant. The retraction mechanismcomprises balloons 130, 132 and retractor supports 174, 176 coupled tothe ovoid assembly 110 at retractor connection portions 134, 136.

Materials

The applicator system 100 can comprise environmentally friendly,disposable and/or recyclable materials. For example, plastics such asDelrin, Peek, GlassPeek, etc. can be used. Stainless steel or othersuitable materials can be used. In some embodiments, use of allergycausing materials such as latex can be avoided. Balloon materials arepreferably very strong, such as, for example, a double-layeredpolyurethane to avoid leaking and/or bursting. In some embodiments, theapplicator is made of MRI and CT friendly materials.

Markers

As discussed above, radiographic markers can be provided along thecatheters. Radiographic markers can be used to identify left and rightovoids 112, 114 by varying the number or style of markings 120, 122 oneach ovoid. Radiographic markers can be provided on the externalsurfaces of the ovoid balloons 112, 114 to identify their placements andensure proper expansion while being treated. Radiographic markers 106can be provided on the tandem spaced one-cm apart to measure the lengthof the tandem 102 and/or to measure the magnification factor on theorthogonal radiographs. The applicator system preferably is adapted tobe gamma ray, and gas sterilizable. The catheters of the applicator arepreferably numbered and marked as corresponding to 1. Right Ovoidcatheter 170, 2. Left Ovoid catheter 172, 3. The Luer Lock 182 inflatingthe Right Ovoid, 4. The Luer Lock 180 inflating the Left Ovoid, 5. TheLuer Locks 184, 186 to inflate the retraction mechanism—one for thebladder and one for the rectum.

Guide Tubes

In some embodiments, the applicator 100 can be connected via three equallength transfer guide tubes or catheters 138, 140, 142 to the high dosebrachytherapy afterloader with a 192-Iridium High Dose Rate (HDR)radioactive source. In some embodiments the transfer guide tubes 138,140, 142 can vary in length. The three transfer guide tubes 138, 140,142 are coupled to the tandem 102 and the pair of inflatable ovoids 112,114.

Radiation Treatment Modifications

In some embodiments, for Low Dose Rate (LDR) brachytherapy a similarlydesigned applicator can be used with either 137-Cs tubes or 192-Iridiumribbons (192Ir seeds on a wire) placed inside plastic transfer guidetubes 138, 140, 142. The internal diameters of the tandem and the ovoidswill be adjusted relative to the HDR applicator design to accommodatethe commercially available 137-Cs tubes. For 192-Iridium ribbons thesame tandem and ovoids designed for HDR can be used without anymodifications to the internal diameter of the tandem and the ovoidcatheters. Other parameters and characteristics of the applicator can besimilar to those described for the HDR applicator. The LDR and HDRisodose distributions are preferably similar to the conventional FSDtandem and ovoids implants, yielding similar doses to the treatmentsite.

Endoscope Assembly

With reference to FIG. 14, in some embodiments, a miniaturizedendoscopic fiber optic bundle 190 is integrated with the tandem 102. Insome embodiments, the fiber optic bundle 190 can be about 1 mm thickalong the length of the tandem 102. The endoscope 104 can be illuminatedby a battery operated LED light and connected to a CMOS or CCD camera.The images preferably can be seen on a display monitor or be captured ina laptop computer connected through a USB2 connector, or other suitableconnector, for further analysis. The eye piece can be attached to acoupler that can be attached to a CMOS or CCD camera and connected to alaptop computer or a display monitor. Endoscopic capabilities of thetandem 102 enables the physician to find the cervical os, guide thetandem into the cervical os and uterine canal, sound the uterus, andinspect the extent of the disease in vagina, cervix, uterine canal, andthe uterus. The endoscope 104 can help the radiation oncologist to guidethe tandem to the end of the uterine canal without perforating it. Amechanism, such as markings on the tandem 106, can be used to measurethe length of the uterine canal from the cervical os to the end of thecanal. This feature helps sound the uterine canal and position theflange on the tandem to limit the risk of the tandem perforating theuterus.

Methods of Use

In some embodiments, the applicator 100 comprises a tandem catheteradapted to be placed in the uterine canal with a cervical os stopper(e.g., a flange with a ring radiographic marker). The ovoid andretractable system assembly (collectively, ORSA) is preferably coupledprior to treatment to form an integrated unit as one part. The ORSA canbe inserted after the tandem is in place. The tandem preferably slidesthrough a central pivoting tract between the two ovoids of the ORSA. TheORSA is inserted inside the vaginal canal until it reaches the cervicalfornices. A separator mechanism on the ORSA can be adjusted to open andseparate horizontally the two ovoids and lock at the desired positionwith a locking knob. The inflatable ovoids can be filled with a mixtureof saline, and 2% iodinated contrast solution through the luer lock foreach ovoid. In some embodiments the ovoids are filled symmetrically. Thesaline volume will be dependent on the size of the fornices, and vaginaldistal circumferential diameter. The inflatable ovoids are preferablymade such that there is at least one cm distance posteriorly from theend of the catheter to the surface of the vaginal mucosa, thus loweringthe dose to the vaginal mucosa and rectum. The adjustable volume of theovoids and bigger diameter will conform to the shape of the fornices andimprove the percentage depth dose to the tumor under treatment. Thepivoting tandem mechanism can be fixed so the tandem bisects the ovoidsand remains locked using a side locking knob. The square-shaped orflattened portion of the tandem is placed in the ovoid tract having asimilar square-shaped or flattened configuration. This acts to limit thetandem from unwanted rotation in the uterine canal. Other shapes can beused to limit rotation of the tandem.

The two inflatable retractors are filled with saline to retract theanterior and posterior wall of the vaginal canal from the plane of theimplant. The retractors can be filled symmetrically in some embodiments.The volume of the saline is adjusted to preferably have at least two cmretraction from the plane of the tandem. An advantage of an embodimentwherein the inflatable retractors are made of soft polyurethanesemi-cylindrical or disc-shaped balloons is that the patient will feelless pain and little pressure. Since insertion of the tandem is followedby the insertion of the assembled single piece ovoid and retractorassembly, the implant time is much shorter compared with devices thatrequire assembly of several components in the patient. Accordingly,patient discomfort and pain is minimal, lowering the need for completeand prolonged anesthetics. Due to adjustable features of the applicator,most of the positioning and adjustments is done remotely outside uterus,cervix, and vagina, making it minimally invasive, lowering patient painand discomfort and number of personnel required for assistance.

In some embodiments, the applicator is designed to have markers everyone centimeter for radiographic identification and has magnificationfactors readily available for dose calculations. The disposable materialmade of high strength plastics (Peek, GlassPeek, Carbon Fiber) orlightweight stainless steel has minimal radiation self absorption,removing the need for dosimetry corrections. The total length of thethree catheters is preferably substantially identical to limit humanerrors during dosimetry calculations. In one embodiment, the applicatoris designed such that the right ovoid will be connected through atransfer guide tube to channel one, the left ovoid to channel two, andthe tandem to channel three of a commercially available 192-Ir HDRafterloader. In some embodiments, the tandem and ovoid system preferablycomprises CT and MRI friendly material, making 3D dosimetry possiblewith no image artifacts.

Once the applicator is removed, the patient can then be allowed to heal.Advantageously, with the use of the applicator systems described herein,the recovery time is reduced compared to conventional treatments due tothe improved dosimetry and limited invasiveness of the treatment.

Additional Features and Advantages of Some Embodiments

FIGS. 15-18 illustrate another assembled minimally invasiveintracavitary brachytherapy applicator system according to embodimentsof the present application. The applicator system of FIGS. 15-18 issimilar in some respects to the systems and embodiments illustrated anddescribed with reference to FIGS. 1-14. Some additional features andadvantages are described below.

With reference to FIGS. 15-18, according to some embodiments, systemsfor treating cervical and/or uterine cancers in brachytherapy with anintracavitary brachytherapy applicator 200 comprise a tandem 202 adaptedfor insertion into a cervix of a patient. The tandem 202 can comprise anendoscopic viewing element 204 to facilitate treatment and one or moreradiographic markers 206.

An ovoid assembly 210 comprises first and second adjustably inflatableovoids 212, 214 and an ovoid support mechanism 216. The ovoid supportmechanism 216 is adapted to support the ovoids 212, 214 and to allow foruser manipulation to control the relative position of the ovoids forinsertion of the ovoids within the fornices of a patient. The first andsecond adjustably inflatable ovoids 212, 214 have a deflatedconfiguration for insertion into a patient and one or more adjustablyinflated configurations for positioning the ovoid assembly duringtreatment. The first and second ovoids 212, 214 may have one or moreradiographic markers. The ovoid assembly 210 comprises a tandemconnector 224 adapted to releasably and adjustably couple the tandem 202to the ovoid assembly 210 to allow for pivotal and translational motionof the tandem 202 relative to the ovoid assembly 210 and to limitrotational movement of the tandem 202 about a longitudinal axis of thetandem.

First and second adjustably inflatable retractors 230, 232 are adaptedto be releasably coupled to the ovoid assembly at first and secondretractor connector portions 234, 236. The first and second inflatableretractors 230, 232 have a deflated configuration for insertion into apatient and an adjustably inflated configuration for retraction oftissue during treatment. The first retractor 230 is adapted to bepositioned to retract the bladder of a patient during treatment and thesecond retractor 232 is adapted to be positioned to retract the rectumof a patient during treatment. The tandem 202 and the first and secondinflatable ovoids 212, 214 are adapted to be coupled to a radioactivesource to deliver an implant radiation dose suitable for cancertreatment at a cancerous cervical treatment site in a patient.

Some embodiments are described in more detail below. The applicatorsystems and methods can have one or more of the following advantageouscharacteristics in some embodiments. For example, the applicator systemof FIGS. 15-18 preferably has a configuration that makes the applicatorsystem easier to implant, less invasive and traumatic for the patient,or provides improved inter-fraction implant geometric reproducibility byincluding one or more of the following features and functionalities inthe system.

The ovoid support mechanism 216 is adapted to support the ovoids 212,214 and to allow for user manipulation to control the relative positionof the ovoids for insertion of the ovoids within the fornices of apatient. The ovoid support mechanism 216 supports first and secondcatheter shafts 240, 242 coupled with the ovoids for deliveringradiation to the ovoids. The ovoid support mechanism 216 also comprisesfirst and second handle portions 244, 246 coupled for pivotal movementrelative to one another. Movement of the handle portions 244, 246relative to each other controls the distance between the first andsecond ovoids 212, 214. The ovoid support mechanism 216 comprises athreaded shaft 248 extending between the first and second handleportions 244 and 246. An adjustment wheel 249 is coupled to a centralportion of the threaded shaft 248.

The first and second handle portions 244 and 246 comprise first andsecond knobs 258, 259 coupled to the handle portions and configured tobe coupled to the threaded shaft 248. In some embodiments the knobscomprise tabs or levers that are pivotally coupled to the handleportions and that are disposed in a first configuration wherein a spring261 located between the handle portion and a proximal portion of theknob urges a distal portion of the knob into engagement with thethreaded shaft 248. With the knobs in the first engaged configuration,the adjustment wheel 249 can be rotated by a user. Rotation of thethreaded shaft 248 provides for fine adjustment to move the handleportions toward or away from each other, to precisely control therelative movement, position, and separation of the of the ovoids 212,214. Additionally, the knobs have a second unengaged configuration. Auser can press down on a proximal portion of the tab or lever againstthe spring force such that a distal portion of the knob disengages withthe threaded shaft. In the disengaged configuration, the user is free tomake large adjustments to the movement, position and separation of theovoids by moving the handle portions toward or away from each other.Thus, the threaded shaft and knob features provide for quick and largeadjustments in position by disengaging the knob from the threaded shaft,while allowing for precise control over the movement and positioning ofthe ovoids in an engaged configuration when the knob features arereleased and the spring forces the knob features into engagement withthe threaded shaft. The relative position of the handle portions 244,246 can be fixed relative to the ovoid support mechanism 216 byreleasing or positioning the knobs to allow the knobs to engage with thethreaded shaft 248. Accordingly, in some embodiments, the two knobs onthe ovoid handles can be pressed to allow the two ovoid balloons to beseparated horizontally in a coarse adjustment mode. In some embodiments,the adjustment wheel between the two ovoid handles allows the two ovoidballoons to be adjusted horizontally in a fine adjustment mode.

A lower portion of the ovoid support mechanism 216 comprises the tandemconnector 224. In some embodiments, the tandem connector is a flexibleclip. The tandem connector 224 preferably comprises a slot 252 forreceiving the tandem 202. In some embodiments, the tandem connector hasa generally horse-shoe-shaped cross-section. The tandem connector can beconfigured to grip the tandem to allow for translational and pivotalcoupling of the tandem to the ovoid support mechanism.

The tandem connector 224 is preferably coupled to the ovoid supportmechanism 216 such that the tandem connector can pivot relative to theovoid support mechanism in some configurations and be clamped inposition in other configurations. In some embodiments, the ovoid supportmechanism comprises one or more handles 265, 267 operatively coupledwith the tandem connector. When the one or more handles are positionedin a first open configuration, the tandem connector 224 can receive andhold a tandem and allow for movement of the tandem distally andproximally, and also allow for pivotal movement of the tandem and tandemconnector relative to the ovoid support mechanism. The configuration ofthe tandem connector when engaged with the tandem preferably limitsrotation of the tandem about a longitudinal axis of the tandem. When theone or more handles are positioned in a second clamped position, thetandem connector is compressed within the ovoid support mechanism 216such that the tandem connector and tandem are generally held in positionto limit movement distally or proximally, and to limit pivotal movement.Accordingly, positioning and adjustment of the tandem relative to theovoid support mechanism is facilitated with the one or more handles inan open configuration and when a desired positioning has been achievedby the user, the one or more handles can be moved to the closedconfiguration to hold the tandem in the desired orientation.

As mentioned above, a tandem connector 224 mechanism is provided forcoupling the tandem 202 with the ovoid assembly 210. The mechanismpreferably enables the tandem 202 to pivot in the anterior/posteriordirection about a point in reference to the ovoids 212, 214 using a clipand clamping mechanism within the ovoid assembly 210 to interface withthe tandem as best seen in FIGS. 16-18. The mechanism also preferablyallows the user to translate and/or pivot the tandem to keep it at themid-plane of the ovoids 212, 214 during treatment. Enabling the user toposition the tandem 202 to bisect the ovoids 212, 214 helps to improveimplant geometry and dose distribution. In some embodiments, the tandemis arranged to limit inadvertent rotation of the tandem 202 duringmanipulation and treatment. Accordingly, the mechanism preferably limitsthe tandem from rotation around a longitudinal axis of the tandem andpermits translational and pivotal motion to achieve an advantageousmid-plane position relative to the ovoids 212, 214.

Retractor balloons 230, 232 are preferably added to the intracavitarybrachytherapy applicator 200 to retract the bladder and the rectum fromthe radiation sources, thus lowering the dose to these criticalstructures. This can reduce, and in some cases eliminate, the need touse of vaginal packing after the applicator is in place. The retractorballoons 230, 232 are coupled to catheters 284, 286 that are preferablyanchored on the ovoid assembly 210. The retractor balloons 230, 232 arepreferably inflated with saline. Other suitable inflation mediums canalso be used. The balloons can be hemispherical when inflated to pushthe vaginal mucosa, bladder, and rectum away from the radiation site.Balloons having other suitable shapes and sizes for providing retractioncan also be used. The retraction mechanism is preferably inflatable toretract the bladder and the rectum by at least about 2 cm away from aplane of the implant defined at the plane of the tandem bisecting theovoids. The retraction mechanism preferably retracts equidistance fromthe plane of the implant. The retraction mechanism comprises balloons230, 232 and retractor supports 274, 276 coupled to the ovoid assembly210 at retractor connection portions 234, 236. The bladder and rectumretractor balloons preferably have attachment mechanisms 277, 279 thatallow for the lengths of the retractor supports 274, 276 to be adjusted.By pressing a spring actuated lock mechanism 281, 283 on the attachmentmechanisms 277, 279, the retractor supports 274, 276 can be movedproximally or distally relative to the attachment mechanisms for thedesired length corresponding to the length of the vaginal canal. Whenthe spring actuated lock mechanism 281, 283 is released, the retractorsupports 274, 276 are held in position and preferably do not moveproximally or distally while in the locked position. After insertion ofthe retractor, the attachment mechanism 277, 279 can be removablycoupled to the ovoid assembly 210. In some embodiments, the attachmentmechanism can be coupled to the ovoid assembly by pressing theattachment mechanism against the ovoid assembly 210. The ovoid assemblypreferably has tabs 285, 287 that engage with tabs 288, 289 on theattachment mechanism 277, 279. As the attachment mechanism is pressedagainst the ovoid assembly, the tabs 288, 289 on the ovoid assemblypreferably engage the tabs 285, 283 on the attachment mechanism suchthat the spring actuated lock mechanism 281, 283 compresses to allow thetabs on the attachment mechanism snap into place between the tabs on theovoid assembly and a surface of the ovoid assembly in a configurationsimilar to a key-lock attachment. Both the bladder and the rectalballoons can have similar attachment configurations to adjust for thelength of the vaginal canal by pressing the spring-actuated lockingmechanism similar to a key-lock attachment. In some embodiments, thebladder retractor is preferably filled with air or a gas to push awaythe bladder from the radiation sources. Compared with a liquid, this maylimit the retractor from leaning over the tandem and ovoid due to itsweight or gravity to displace or change its optimal geometry. The rectumretractor is preferably filled with saline to push away the rectum fromthe source of radiation. The saline weight due to gravity will push awaythe rectum from the sources of radiation. In some embodiments, bothretractors are suitable to be filled with either a gas or a liquid, suchas for example, air or saline.

With reference to FIGS. 15-18, in some embodiments, a miniaturizedendoscopic fiber optic bundle 290 is integrated with the tandem 202. Insome embodiments, the fiber optic bundle 290 can be about 1 mm thickalong the length of the tandem 202. An endoscope can be illuminated by abattery operated LED light and connected to a CMOS or a CCD camera. Insome embodiments, the tandem may have a high resolution fiber opticbundle of up to 10000 pixels, or more, for finding the cervical os,connected to a CCD or CMOS high resolution camera. The CCD or CMOScamera output may be connected to a laptop computer via USB2 or USB3connector, or another connector, or wirelessly connected, to displaystatic and/or video images of the cervix, cervical os, and uterinecanal. The camera may be used for image guidance to find the cervicalos, or to guide the tandem into the uterine canal all the way to the endwithout perforating the uterus. In some embodiments, an alternativeconfiguration to the optical fiber bundle-camera is a miniaturizedultrasound transducer to perform these or other functions and that isconfigured to be attached to a display to view the ultrasound picturesof the cervical os, uterine canal, and evaluate the extent of disease orresponse to cancer to treatments.

Visualization capabilities of the tandem 202 enables the physician tofind the cervical os, guide the tandem into the cervical os and uterinecanal, sound the uterus, and inspect the extent of the disease invagina, cervix, uterine canal, and the uterus. The visualization canhelp the radiation oncologist to guide the tandem to the end of theuterine canal without perforating it. A mechanism, such as markings onthe tandem 206, can be used to measure the length of the uterine canalfrom the cervical os to the end of the canal. This feature helps soundthe uterine canal and position the flange on the tandem to limit therisk of the tandem perforating the uterus.

In some embodiments, methods of using the applicator 200 are similar tomethods described previously in connection with other embodiments. Withreference to FIGS. 15-18, in some embodiments, handles on the ovoidassembly can be adjusted to open and separate horizontally the twoovoids and lock at the desired position. In some embodiments, the twoknobs on the ovoid handles can be pressed to allow the two ovoidballoons to be separated horizontally in a coarse adjustment mode. Insome embodiments, the adjustment wheel between the two ovoid handlesallows the two ovoid balloons to be adjusted horizontally in a fineadjustment mode. The inflatable ovoids can be filled with a fluid. Thepivoting tandem mechanism can be adjusted or fixed so the tandem bisectsthe ovoids and remains locked using a tandem handle clamping mechanism.The two inflatable retractors are filled with fluid to retract theanterior and posterior wall of the vaginal canal from the plane of theimplant. The length and positioning of the retractors can be adjusted bypressing the spring actuated lock mechanism and manipulating theretractor supports to the desired length relative the attachmentmechanism. The attachment mechanism for the retractor can be pressedagainst the ovoid assembly to snap the retractors into position. Due toadjustable features of the applicator, most of the positioning andadjustments is done remotely outside uterus, cervix, and vagina, makingit minimally invasive, lowering patient pain and discomfort and numberof personnel required for assistance. Visualization of the procedure canbe made as described above. Once the applicator is removed, the patientcan then be allowed to heal. Advantageously, with the use of theapplicator systems described herein, the recovery time is reducedcompared to conventional treatments due to the improved dosimetry andlimited invasiveness of the treatment.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the present embodiments andmethods without departing from the scope or spirit of the advantages ofthe present application. Thus, it is intended that the presentapplication cover the modifications and variations of these embodimentsand their equivalents.

1. (canceled)
 2. A system for treating cervical and/or uterine cancersin brachytherapy with an intracavitary brachytherapy applicator,comprising: a tandem adapted for insertion into a cervix of a patient,the tandem comprising a longitudinal portion and an angled portiondisposed at an angle relative to the longitudinal portion; an ovoidassembly comprising first and second inflatable ovoids and an ovoidsupport mechanism, the first and second inflatable ovoids adapted forinsertion within fornices of a patient, wherein the ovoid supportmechanism is adapted to support the ovoids and to allow for usermanipulation to control the relative position of the ovoids forinsertion of the ovoids within the fornices of a patient, the ovoidassembly adapted to be pre-assembled as a single unit and configured tobe simultaneously inserted into the patient as integrated pieces of thesingle unit prior to insertion into a vagina of the patient, the ovoidsupport mechanism comprising first and second handles configured toallow angular movement of the corresponding first and second inflatableovoids; and first and second retractors adapted to be coupled to theovoid assembly, wherein the first retractor is adapted to be positionedto retract the bladder of a patient during treatment and the secondretractor is adapted to be positioned to retract the rectum of a patientduring treatment; wherein the tandem and the first and second inflatableovoids are adapted to be coupled to a radioactive source to deliver animplant radiation dose suitable for cancer treatment at a cancerouscervical treatment site in a patient.
 3. The system of claim 2, whereinthe tandem comprises an endoscopic viewing element to facilitatepositioning of the tandem.
 4. The system of claim 2, wherein the ovoidassembly comprises a tandem connector adapted to releasably andadjustably couple the tandem to the ovoid assembly.
 5. The system ofclaim 2, wherein the ovoid assembly comprises a tandem connector adaptedto allow for translational motion of the tandem relative to the ovoidassembly prior to insertion into the vagina but adapted to limittranslational motion of the tandem thereafter.
 6. The system of claim 2,wherein the ovoid assembly comprises a tandem connector adapted to allowfor translational motion of the tandem relative to the ovoid assembly.7. The system of claim 2, wherein the ovoid assembly comprises a tandemconnector adapted to limit rotational movement of the tandem about alongitudinal axis of the tandem.
 8. The system of claim 2, wherein thefirst and second retractors are adapted to be releasably coupled to theovoid assembly.
 9. A system for treating cervical and/or uterine cancersin brachytherapy with an intracavitary brachytherapy applicator,comprising: a tandem adapted for insertion into a cervix of a patient,the tandem comprising a longitudinal portion and an angled portiondisposed at an angle relative to the longitudinal portion; an ovoidassembly comprising first and second inflatable ovoids and an ovoidsupport mechanism, the first and second inflatable ovoids adapted forinsertion within fornices of a patient, wherein the ovoid assemblycomprises a tandem connector adapted to releasably and adjustably couplethe tandem to the ovoid assembly, wherein the ovoid assembly is adaptedto be pre-assembled as a single unit and configured to be simultaneouslyinserted into the patient as integrated pieces of the single unit priorto insertion into a vagina of the patient; and first and secondretractors adapted to be coupled to the ovoid assembly, wherein thefirst retractor is adapted to be positioned to retract the bladder of apatient during treatment and the second retractor is adapted to bepositioned to retract the rectum of a patient during treatment; whereinthe tandem and the first and second inflatable ovoids are adapted to becoupled to a radioactive source to deliver an implant radiation dosesuitable for cancer treatment at a cancerous cervical treatment site ina patient.
 10. The system of claim 9, wherein the tandem comprises anendoscopic viewing element to facilitate positioning of the tandem. 11.The system of claim 9, wherein the ovoid support mechanism is adapted tosupport the ovoids and to allow for user manipulation to control therelative position of the ovoids for insertion of the ovoids within thefornices of a patient.
 12. The system of claim 9, wherein the first andsecond inflatable ovoids are adjustably inflatable, having a deflatedconfiguration for insertion into a patient and one or more adjustablyinflated configurations for positioning the ovoid assembly duringtreatment.
 13. The system of claim 9, wherein the first and secondretractors are adapted to be releasably coupled to the ovoid assembly.14. The system of claim 9, wherein the first and second retractors areinflatable.
 15. The system of claim 9, wherein the first and secondretractors are adjustably inflatable, having a deflated configurationfor insertion into a patient and one or more adjustably inflatedconfigurations for retraction of tissue during treatment.
 16. A systemfor treating cervical and/or uterine cancers in brachytherapy with anintracavitary brachytherapy applicator, comprising: a tandem adapted forinsertion into a cervix of a patient; an ovoid assembly comprising firstand second inflatable ovoids and an ovoid support mechanism, the firstand second inflatable ovoids adapted for insertion within fornices of apatient, at least one of the first or second inflatable ovoidsconfigured to move substantially within a plane of motion; and first andsecond retractors adapted to be coupled to the ovoid assembly, first andsecond retractors coupled substantially within a plane different fromthe plane of motion of the at least first or second inflatable ovoids,wherein the first retractor is adapted to be positioned to retract thebladder of a patient during treatment and the second retractor isadapted to be positioned to retract the rectum of a patient duringtreatment, wherein the first and second retractors are adapted to bereleasably coupled to the ovoid assembly, the first and secondretractors having attachment mechanisms adapted to provide foradjustment of the position of the retractor; wherein the tandem and thefirst and second inflatable ovoids are adapted to be coupled to aradioactive source to deliver an implant radiation dose suitable forcancer treatment at a cancerous cervical treatment site in a patient.17. The system of claim 16, wherein the tandem comprises an endoscopicviewing element to facilitate positioning of the tandem.
 18. The systemof claim 16, wherein the ovoid support mechanism is adapted to supportthe ovoids and to allow for user manipulation to control the relativeposition of the ovoids for insertion of the ovoids within the fornicesof a patient.
 19. The system of claim 16, wherein the ovoid assemblycomprises a tandem connector adapted to releasably and adjustably couplethe tandem to the ovoid assembly.
 20. The system of claim 16, whereinthe ovoid assembly comprises longitudinal and angled portions, theangled portion forming an angle with the longitudinal portion, whereinat least one of the first and second ovoids is coupled to the angledportion of the ovoid assembly.
 21. The system of claim 16, furthercomprising first and second handle portions each configured to supportcorresponding radiation transfer catheter shafts for deliveringradiation therethrough, wherein the ovoid assembly is adapted to bepre-assembled as a single unit and configured to be simultaneouslyinserted into the patient as integrated pieces of the single unit priorto insertion into a vagina of the patient.